NRx Pharmaceuticals announces alignment with FDA on study plan for NRX-100

NRx Pharmaceuticals announced a communication from the FDA providing feedback and alignment on NRx’s proposed initial Pediatric Study Plan, or iPSP, for NRX-100 – ketamine – in the treatment of suicidal depression. Congress required the submission of an iPSP as a precondition to filing a NDA in the 2012 Food and Drug Administration Safety and Innovation Act. In support of its upcoming NDA filing, NRx will be submitting existing data supporting the safety and efficacy of ketamine to treat suicidal depression in adults. Based on the guidance received, NRx and HOPE Therapeutics will commit to conducting a clinical trial of NRX-100 in adolescents aged 9-17 with suicidal depression, but will not be required to study the effects of NRX-100 in younger age groups, following initial approval of NRX-100 in adults. Additional neurotoxicity studies will be conducted in juvenile animal subjects to support the safety of intravenous ketamine in this younger population.